Medical device eye pack manufactured by DeRoyal Industries recalled
DeRoyal Industries voluntarily recalled 72 kits of its EYE PACK medical device. The affected lot (Lot 57344921, exp. November 1, 2026) was distributed across multiple U.S. states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall initiated voluntarily by the manufacturer with no reported illnesses, injuries, or deaths. Without specification of the underlying defect or hazard, the classification defaults to Moderate severity for a voluntary Class II medical device recall.
Plain-English summary
DeRoyal Industries Inc initiated a voluntary recall of 72 kits of the DeRoyal EYE PACK medical device (Reference 89-8756.03) on November 3, 2022. The FDA classified this as a Class II recall.
The recalled product is identified by Lot 57344921 (expiration date November 1, 2026). This lot was distributed to customers across 23 U.S. states, including Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.
The public notice does not specify the reason for this recall. Healthcare facilities and consumers with the affected lot should contact DeRoyal Industries Inc or monitor FDA communications for further details and any necessary actions.
The recalled product
- Product
- DeRoyal EYE PACK, REF 89-8756.03
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Eye Care Device
- Affected units
- 72
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: Lot 57344921 exp 11/1/2026
Distribution
Part of a larger recall action
This product is one of 156 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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